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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO 244 S DE RL DE CV AVIATOR PLUS .014 6.0X40 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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CARDINAL HEALTH MEXICO 244 S DE RL DE CV AVIATOR PLUS .014 6.0X40 142CM CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problems Stroke/CVA (1770); Vasoconstriction (2126)
Event Date 10/14/2021
Event Type  Injury  
Event Description
During post-dilatation of an 8mm x 4mm precise stent with a 5mm x 4cm aviator plus balloon catheter, the physician was unable to successfully withdraw the balloon catheter. The removal caused movement of the angioguard embolic protection device in place, resulting in severe spasm of the left internal carotid artery. It also resulted in transient thrombotic occlusion of the internal carotid artery and the patient suffered a stroke. There was also difficulty closing and removing the angioguard device which was removed partially collapsed. The thrombus was aspirated. The patient suffered a stroke complaining of right arm and leg weakness, expressive dysphasia and confusion. An urgent ct scan was performed and this did not reveal any acute stroke or haemorrhage. The patient was treated conservatively by the radiology nursing staff and made a significant recovery in the radar analysis and development unit (radu). The patient was converted from aspirin to clopidogrel. The patients arm and leg weakness resolved, he was less confused but still had some residual expressive dysphasia. A left carotid stenting procedure was being performed. Under ultrasound guidance a left common femoral artery puncture was performed and a short 6 inserted. The patient was 5000 units of heparin intravenously. Selective catheterization was performed to the left common carotid artery using a 5 french catheter. Angiography demonstrated a high-grade focal stenosis at the origin of the internal carotid artery. A long 6 french sheath was inserted into the common carotid artery. The stenosis was crossed intraluminal using a 5 mm angioguard. The stenosis was predilated uneventfully using a 3 mm x 4 cm balloon. An 8 mm x 4 cm cordis precise stent was deployed uneventfully. The stent was post-dilated uneventfully using a 5 mm x 4 cm balloon. There was still a residual stenosis and therefore further balloon dilatation was attempted using a 6 mm x 4 cm balloon. There was marked resistance to during the distal portion balloon catheter over the guide wire. Numerous maneuvers were attempted to remove the balloon catheter is all unsuccessful. Considerable force was required, and this resulted in movement of the angioguard filter protection device. The force needed to remove balloon which resulted in movement of the angioguard filter protection device which resulted in severe spasm in the left internal carotid artery. Eventually the balloon was removed. Attempts were made to remove and close the filter protection device. This was also problematic due to the presence of a large amount of fresh thrombus in the distal filter. This was eventually removed partially collapsed. The sheath was withdrawn from the carotid artery and a large amount of thrombus aspirated. Eventually the left carotid artery cleared. There was no obvious result filling defect and the intracranial circulation appeared preserved. An angioseal was deployed to the groin to achieve hemostasis. The aviator will be returned for analysis.
 
Manufacturer Narrative
This device is available for analysis but has not yet been received. A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan. This is one of three devices associated with the reported event but the related numbers will be provided in the related reports. Additional information is pending and will be submitted within 30 days upon receipt.
 
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Brand NameAVIATOR PLUS .014 6.0X40 142CM
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
CARDINAL HEALTH MEXICO 244 S DE RL DE CV
santiago troncoso 808
juarez 32574
MX 32574
Manufacturer (Section G)
CARDINAL HEALTH MEXICO 244 S DE RL DE CV
santiago troncoso 808
juarez 32574
MX 32574
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key12778478
MDR Text Key281590031
Report Number9616099-2021-05043
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K071189
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number4246040W
Device Lot Number82201996
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/09/2021 Patient Sequence Number: 1
Treatment
PRECISE AND ANGIOGUARD
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